Device product
WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
Z-1924-2020
Product summary
- Event
- Event 85439
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22 units
- Official record key
device-enforcement:Z-1924-2020
Official wording
Reason: One lot of INBONE Tibial Trays is missing the plasma coating.
Code information: Lot code 1619947
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
One lot of INBONE Tibial Trays is missing the plasma coating.